**Product Overview**Manufacturer: LionProduct Name: Bufferin Premium DX 40 TabletsMedical Drug Classification: Designated Class 2 Medical DrugCategory: OTC (Over-the-Counter) MedicinePediatric Use Category: For Adults (Only dosage and usage for adults (15 years and older))Dosage Form: Tablets, Round Tablets, CapsulesContents: 40 TabletsProduct Description: Bufferin includes products with different active ingredients. The antipyretic and analgesic ingredients in this product are Ibuprofen and Acetaminophen.【Expiration Date】At the time of shipment, there is more than one year remaining until the expiration date.JAN Code: 4903301303596Product Code: 051412303
**Initial and Revision Dates of the Package Insert, and Version Number**Initial Creation: —Revision: —
**Features**Bufferin has products with different active ingredients. The antipyretic and analgesic ingredients in this product are Ibuprofen and Acetaminophen. When consulting a doctor, dentist, pharmacist, or registered seller, please specify Ibuprofen and Acetaminophen.
**Do Not Take If You**1. Are allergic to this medicine or any of its ingredients, having previously experienced allergic reactions.2. Have experienced asthma or allergic reactions after taking this medicine or other antipyretic/analgesic or cold medicines.3. Are under 15 years old.4. Are receiving treatment or medication for the following conditions at a medical institution:- Gastric or duodenal ulcers- Blood disorders- Liver disease- Kidney disease- Heart disease- Hypertension- Taking Zidovudine (Retrovir)(Note: Those with gastric/duodenal ulcers, liver or kidney disease may experience worsening symptoms. Blood disorder patients may experience leukopenia or thrombocytopenia, which could worsen. Heart disease patients may experience further deterioration of cardiac function. Hypertensive patients may see increased blood pressure.)5. Are pregnant within 12 weeks of the expected delivery date.
**While Taking This Medicine, Do Not**- Take other antipyretic/analgesic medicines, cold medicines, sedatives, or motion sickness medicines.
**Do Not Consume Alcohol Before or After Taking**(Generally, alcohol can promote the absorption and metabolism of the drug, potentially increasing side effects or toxicity, and may cause severe liver damage.)
**Do Not Use Continuously for Long Periods**
**Consultation Before Use**1. Please consult a doctor, dentist, pharmacist, or registered seller before taking if you are:- Under medical treatment- Pregnant or suspected to be pregnant- Breastfeeding- Elderly (generally, older adults may experience stronger side effects due to decreased physiological functions)- Have experienced allergic reactions to medicines or other substances- Diagnosed with or have had the following conditions:- Gastric or duodenal ulcers, blood disorders, liver or kidney disease, heart disease, hypertension, bronchial asthma (may trigger asthma), systemic lupus erythematosus (may worsen symptoms or cause aseptic meningitis), mixed connective tissue disease (may cause aseptic meningitis), ulcerative colitis, Crohn’s disease (may worsen symptoms)
2. If any of the following symptoms appear after taking, immediately stop use and consult a doctor, dentist, pharmacist, or registered seller with this document:
**Related Parts and Symptoms:**- Skin: Rash, redness, itching, bruising- Digestive System: Nausea, vomiting, loss of appetite, stomach discomfort, stomach pain, stomatitis, heartburn, indigestion, gastrointestinal bleeding, abdominal pain, diarrhea, bloody stool- Nervous System: Dizziness, drowsiness, insomnia, mood depression- Circulatory System: Palpitations- Respiratory System: Shortness of breath- Others: Blurred vision, tinnitus, swelling, nosebleeds, gum bleeding, bleeding that is hard to stop, bleeding, back pain, excessive hypothermia, fatigue
**Serious Symptoms (Rare Cases):**If these occur, seek immediate medical attention.
**Symptoms and Conditions:**- Shock (Anaphylaxis): Immediate symptoms include skin itching, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, altered consciousness.- Stevens-Johnson Syndrome: High fever, eye redness, eye discharge, lip sores, sore throat, widespread skin rash/redness, small pustules on red skin, persistent or rapidly worsening fatigue, loss of appetite.- Toxic Epidermal Necrolysis: Similar to above, with high fever, eye redness, lip sores, sore throat, widespread rash, pustules, fatigue, loss of appetite.- Acute Generalized Exanthematous Pustulosis: Similar symptoms as above.- Drug Hypersensitivity Syndrome: Widespread redness, systemic rash, fever, fatigue, swollen lymph nodes (neck, armpits, groin).- Digestive Disorders: Black stools, vomiting blood, bloody stool, mucus/blood mixed soft stool.- Liver Dysfunction: Fever, itching, rash, jaundice (yellowing of skin and eyes), dark urine, fatigue, loss of appetite.- Kidney Disorder: Fever, rash, decreased urine output, swelling, fatigue, joint pain, diarrhea.- Aseptic Meningitis: Severe headache with neck stiffness, fever, nausea, vomiting (especially reported in patients with systemic lupus erythematosus or mixed connective tissue disease).- Interstitial Pneumonia: Shortness of breath, cough, fever that appears suddenly or persists.- Asthma: Wheezing, whistling sounds, difficulty breathing.- Aplastic Anemia: Bruising, nosebleeds, gum bleeding, fever, pallor, fatigue, palpitations, shortness of breath, dizziness, hematuria.- Agranulocytosis: Sudden high fever, chills, sore throat.
3. If any of the following symptoms persist or worsen, stop use and consult a doctor, pharmacist, or registered seller with this document:- Constipation, dry mouth.
4. After taking, symptoms such as a body temperature lower than normal, weakness (collapse), cold limbs may occur. If so, stop use immediately, keep warm with blankets, and consult a healthcare professional.
5. If symptoms do not improve after 3-4 doses, stop use and consult a doctor, dentist, pharmacist, or registered seller with this document.
**Efficacy and Effects**(1) Pain relief for headache, shoulder stiffness, menstrual pain, lower back pain, joint pain, neuralgia, muscle pain, sore throat, toothache, post-extraction pain, bruises, sprains, fractures, injuries, ear pain.(2) Fever reduction during chills and fever.
**Usage and Dosage**Avoid taking on an empty stomach as much as possible. Maintain a minimum interval of 4 hours between doses. Take the following amount with water or lukewarm water:
【Age: Single Dose: Daily Frequency】- Adults (15 years and older): 2 tablets, up to 2 times a day. If symptoms reappear, a third dose can be taken.- Under 15 years: Do not take.
**Precautions Related to Usage and Dosage**(1) Strictly adhere to the prescribed dosage and instructions.(2) How to remove tablets: As shown in the diagram, press firmly on the protruding part of the PTP (press-through package) sheet with your fingertips to break the aluminum foil on the back, then take out the tablet and swallow.*Note:* Do not swallow the tablet directly without breaking the foil, as this may cause accidental injury to the esophageal mucosa.
**Ingredients and Amounts per Tablet**- Ibuprofen: 160 mg- Acetaminophen: 160 mg- Anhydrous Caffeine: 50 mg- Dried Aluminum Hydroxide Gel: 70 mg
**Storage and Handling Precautions**(1) Store in a cool, dry place away from direct sunlight.(2) Keep out of reach of children.(3) Do not transfer to other containers to prevent misuse or quality deterioration.(4) Do not use products past the expiration date.(5) Do not damage the aluminum foil on the back of unused tablets, as this may cause deterioration.
**Contact Information**Lion Corporation Customer CenterPhone: 0120-813-752Hours: 9:00–17:00 (excluding Saturdays, Sundays, and holidays)
**Manufacturer**Lion
**Contents**40 Tablets
**Suggested Retail Price**1,958 yen (tax included)
**OTC Drug Classification**Designated Class 2 Medical Drug
**Poison and Quasi-Drug Category**Not classified as poison or quasi-drug
**Pesticide/Animal Drug Category**Not classified as pesticide or animal drug
**Dosage Form Category**Tablet
**Pediatric Use Category**For Adults (only dosage and usage for those 15 and older)
**Product Category**OTC Medicine
**Disclaimer**【Notice】- The product descriptions above, excluding price information, are provided by the manufacturer or the Self-Medication Database Center.- If you have any questions or concerns about using this medicine, please consult a doctor or pharmacist.- We assume no responsibility for health damages caused by taking medicines purchased through this service.
**Self-Medication Tax Deduction Eligible Product**
| Product # | TH051412303 |
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